LONDON, April 19 (Reuters) - The World Health
Organization is likely to issue a wider warning about
contaminated Johnson and Johnson ( JNJ )-made children's cough
syrup found in Nigeria last week, it said in an email.
Nigeria's regulator recalled a batch of Benylin syrup last
Wednesday, having found a high level of diethylene glycol in the
product during routine testing.
The contaminant, alongside another closely related toxin,
has been linked to the deaths of more than 300 children in
Gambia, Uzbekistan, Indonesia and Cameroon since 2022, though
there is no evidence that these incidents are linked with the
new recalls.
The U.N. health body said it puts out global medical product
alerts to "encourage diligence" by national authorities and was
likely to do so in this instance, "subject to confirmation of
certain details from parties".
The batch of Benylin syrup recalled was made by J&J in South
Africa in May 2021, although Kenvue ( KVUE ) now owns the brand
after a spin-off from J&J last year.
J&J has referred requests for comment to Kenvue ( KVUE ). Kenvue ( KVUE ) was
not immediately available for comment, but said this week it was
conducting its own assessment and working with health
authorities to determine a course of action.
Since Nigeria's recall, five other African countries have
also pulled the product from shelves - Rwanda, Kenya, Tanzania,
Zimbabwe and South Africa, where the drug was made.
South Africa's regulator has also recalled another batch of
the syrup, which is used to treat coughs, hay fever and other
allergic reactions in children.
Diethylene glycol is toxic to humans when consumed and can
result in acute kidney failure, although there have been no
reports of harm in the latest incident.
In the 2022 cases, the contamination in the syrups came from
the raw materials used by manufacturers in India and Indonesia.
The WHO said it was collaborating with both the manufacturer
and regulatory authority in South Africa to investigate this for
the Benylin paediatric syrup, and had information on the source
of the raw ingredients used. It did not disclose the source.
According to WHO, Kenvue ( KVUE ) said it tested the raw ingredients
used in the syrup before manufacture, and "no issues of concern
were noted".
The agency said the possibility that the syrup was
counterfeit was also "under consideration as part of
investigations".